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FDA Drug Application 019386 by BAXTER HLTHCARE

Application Number	019386
Application Type	New Drug Application
Sponsor Applicant	BAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/31/1986	N	10325	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-386_ Brevibloc.cfm	10/4/2004
AP	8/15/1988	SCP	18623	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf	12/6/2007
AP	8/15/1988	SLR	18624	002	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf	12/6/2007
AP	12/18/1992	SE1
AP	8/15/1988	SCS	18625	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf	12/6/2007
AP	5/26/1989	SCM	18627	005	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S005_BREVIBLOC.pdf	12/6/2007
AP	8/15/1988	SLR	18626	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf	12/6/2007
AP	5/11/1989	SLR	18628	007	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S007_BREVIBLOC.pdf	12/6/2007
AP	12/18/1992	SE2
AP	10/21/1991	SLR	19156	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S009_BREVIBLOC_INJECTION.pdf	2/19/2008
AP	7/1/1993	SLR	19157	010	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S010_BREVIBLOC_INJECTION.pdf	2/19/2008
AP	11/24/1993	SCS	19158	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S011_BREVIBLOC.pdf	2/19/2008
AP	1/13/1994	SCS	19159	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S012_BREVIBLOC.pdf	2/19/2008
AP	10/4/1995	SLR
AP	2/23/2000	SCM	17884	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019386_S015_BREVIBLOC_INJECTION.pdf	9/14/2007
AP	1/19/2000	SLR
AP	1/26/2001	SCS	17885	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S017_BREVIBLOC_INJECTION.pdf	9/14/2007
AP	2/16/2001	SCP	17886	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S018_BREVIBLOC_INJECTION.pdf	9/14/2007
AP	1/27/2003	SCF	4834	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf	1/27/2003
AP	1/27/2003	SCF	4331	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf	1/27/2003
AP	2/25/2003	SCF	4264	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf021ltr.pdf	3/10/2003
AP	2/25/2003	SCF	6102	021	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-386s021.cfm	7/8/2003
AP	5/28/2003	SCM	5748	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scm022ltr.pdf	5/30/2003
AP	5/28/2003	SCM	17132	022	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019386_S022_Brevibloc.pdf	7/6/2007
AP	8/18/2003	SCF	6538	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf024ltr.pdf	8/26/2003
AP	11/6/2007	SLR	18343	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf	11/7/2007
AP	11/6/2007	SLR	18367	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019386s039ltr.pdf	11/8/2007
AP	8/13/2013	SCM
AP	12/11/2012	SLR	34620	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf	12/13/2012
AP	12/11/2012	SLR	34655	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019386Orig1s043ltr.pdf	12/13/2012
AP	3/20/2014	SCM
AP	1/26/2015	SCM
AP	8/14/2015	SCM

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